InfertilityNCT02418364
The Effect of Reflexology Treatments on IVF Outcome
A study testing Reflexology treatment in people with Infertility, run by Meir Medical Center.
Trial summary
Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end. It is often said that the couple suffers from infertility if for a year they could not get a normal pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Reflexology treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women age 18 To 42
- women who receive IVF treatment
- The number of IVF cycles - up to 7 cycles
- Signing an informed consent form.
- patient is required to receive at least 4 reflexology treatments until the eggs implant.
Who cannot join
- Women under 18 or over 42
- patients who had 7 cycles of IVF
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomised ,Blind, Placebo Controlled in Meir Center. Study the Potential of Reflexology Treatments to Help Implant Pregnancy in Ivf Patients
Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end. It is often said that the couple suffers from infertility if for a year they could not get a normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30% are attributed to men, while the other 40% of cases are attributed to the combination between men and women and for unknown reasons. In women, the source of most of the problems of infertility are associated with different failures in ovulation (early ovulation, lack of ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to endometriosis, infection or surgery), problems in the uterus and endometrium. There is a group of women that apparently does not have the failures described above, and they have infertility that does not include pathological findings. Apparently chronic stress is a potential cause among couples who could not get pregnant (despite 6 months of focused sex) so there is a request for various techniques for reducing stress including yoga and meditation. One common option in various conditions of infertility is in vitro fertilization. This technique is also known as artificial insemination and is the most common technique used in Israel. Data from the Ministry of Health from the last years, indicate that the rate of successful pregnancies after embryo transfer is more than a third (in average), this is from an average of 20 treatment cycles.
Researches in alternative medicine are not easy to carry out. The placebo group which is usually the control group tend to be a treatment group by itself and gives effective results than a group that does not receive treatment at all. Carrying out a strict study with a good control group such as reflexology research in multiple sclerosis, has brought significant results in various statistical measures examined in this study (movement, sensory mode and urinary tract symptoms).
In the control group the calf was chosen as a place of a massage as a dummy treatment (gynecological place), which prevented contact with specific points of the feet like in patients in the treatment group. This study wishes to answer the research question: Does reflexology treatment increase the chances of pregnancy implantation in women without pathological findings that are treated with IVF. Other questions related to measures that could lead to the implant of pregnancy, are whether reflexology treatment affect the endometrial thickness, number of oocytes and embryo quality. Literature indicates the potential of reflexology treatment on ovulation induction (But requires a good control group and large sample size).
Read the detailed description
The purpose of the study:
Does reflexology treatment increase the chance of pregnancy in women treated with IVF?
Research design:
To the Study will recruited women who come for IVF treatments.
Women who are fit to participate and give their consent, will be randomized to one of three treatment groups:
Group 1 - placebo reflexology
Group 2 - control group that receives no alternative treatment. Data will be taken from questionnaires
Group 3 - will be receiving a built-in protocol reflexology treatment
Reflexology treatment can begin at any stage up to the stage of the eggs implantation. If the patient is not pregnant, she will start another reflexology treatment cycle. Reflexology treatment will be minimum 4 treatments and up to six treatments for every cycle. Rate treatment will be two or three times a week. The patient can receive reflexology treatment for three cycles of IVF.
Research tools and methods
- Photo of feet before the first treatment and before final treatment
- Permanent set by 4 parameters
- Questionnaire: to be transferred at baseline and after treatment and will be in a state of double blinded. There will be no connection between the treatment protocol and questionnaires. At the end of the study, the analysis and cross checking data will form their own measurements.
- Quality of Life Questionnaire
- Questionnaire "dhak"
- Mind-body questionnaire
- Family support questionnaire
Medical tests (measurements taken any way and will be used for the study): blood tests, medical record indicating that there is no pathological findings, ultrasound, endometrial thickness, number of follicles, number of oocytes and embryo quality.
Evaluation of Participants:
80 - experimental group 80 - a control group that receives no alternative treatment 80 - a group that receives a placebo treatments
Duration of participation in the study: Six months
Treatment protocol:
The treatment strengthens the natural healing of the body, in that it strengthens the blood flow and the release of endorphins, which can reduce pain, stress relaxation and a general feeling better (wellbeing). Recently a promising theory was added, a theory called Nerve Impulse the suggests that pressure points in the foot improve neural connection to other parts of the body through the autonomic nervous system. The autonomic nervous system, regulates body systems that are under unaware control such as respiratory, heart rate and blood pressure systems which are sensitive to pressure and vibration in accordance with Physical and psychological changes, and able to control the sympathetic system and moderate the fight or flight response. Recent meta-analysis that scanned many articles pointed out that there is no unity in studies about reflexology, that there are a wide range of parameters, methods and measurements of efficacy .Therapeutic Touch are complex and it is difficult to maintain such double-blind trials.
Therefore, there is a great need for maintaining the uniformity of treatment. In the investigators' study, will be responsible coordinator of reflexology, Rachel Hoddov, to teach and train coaches participating in the study protocol the standard treatment in a way that will allow a free hand. In addition, Placebo treatment will be in superficial areas in particular, and will be directed to organs and organ systems which are not relevant to the research topic.
- Conditions
- Infertility
- Being tested
- Placebo reflexology treatment, Reflexology treatment
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo reflexology treatmentOther
Placebo reflexology treatment will be done in the same rate as the reflexology treatment itself, but will be superficial in particular,and will be directed to organs and organ systems which are not relevant to the research topic.
Reflexology treatmentOther
Reflexology treatment will be done until the eggs implant. If the patient is not pregnant, she will start another reflexology treatment cycle. There will be minimum 4 and up to 6 reflexology treatments in every IVF cycle (maximum three IVF cycles) . Rate treatment will be two or three times a week.
| Study group | Role | What they receive |
|---|---|---|
| placebo reflexology | Placebo comparator | Placebo reflexology treatment Receives: Other: Placebo reflexology treatment |
| control group | No intervention | Data will be taken from questionnaires |
| reflexology treatment | Experimental | Reflexology treatment Receives: Other: Reflexology treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of pregnant women in women treated with implantation in IVF
Does reflexology treatment increase the number of pregnant women in women treated with implantation in IVF
Measured: 6 Months
Secondary outcomes (3)
endometrial thickness
Measured: 6 months
number of oocytes
Measured: 6 months
embryo quality
Embryo quality measured according to the ESHRE score. Grades 1-4
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Reidman college
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418364
- Sponsor's protocol ID
- 0020-15
- Status last verified
- Feb 2015
- First submitted
- 4 Mar 2015
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Templeton A. Infertility-epidemiology, aetiology and effective management. Health Bull (Edinb). 1995 Sep;53(5):294-8.
PubMed 7490200Ernst E. Is reflexology an effective intervention? A systematic review of randomised controlled trials. Med J Aust. 2009 Sep 7;191(5):263-6. doi: 10.5694/j.1326-5377.2009.tb02780.x.
PubMed 19740047Poole H, Glenn S, Murphy P. A randomised controlled study of reflexology for the management of chronic low back pain. Eur J Pain. 2007 Nov;11(8):878-87. doi: 10.1016/j.ejpain.2007.01.006. Epub 2007 Apr 24.
PubMed 17459741Siev-Ner I, Gamus D, Lerner-Geva L, Achiron A. Reflexology treatment relieves symptoms of multiple sclerosis: a randomized controlled study. Mult Scler. 2003 Aug;9(4):356-61. doi: 10.1191/1352458503ms925oa.
PubMed 12926840Holt J, Lord J, Acharya U, White A, O'Neill N, Shaw S, Barton A. The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial. Fertil Steril. 2009 Jun;91(6):2514-9. doi: 10.1016/j.fertnstert.2008.04.016. Epub 2008 Jun 20.
PubMed 18565520Sudmeier I, Bodner G, Egger I, Mur E, Ulmer H, Herold M. [Changes of renal blood flow during organ-associated foot reflexology measured by color Doppler sonography]. Forsch Komplementarmed. 1999 Jun;6(3):129-34. doi: 10.1159/000021238. German.
PubMed 10460981Hughes CM, Krirsnakriengkrai S, Kumar S, McDonough SM. The effect of reflexology on the autonomic nervous system in healthy adults: a feasibility study. Altern Ther Health Med. 2011 May-Jun;17(3):32-7.
PubMed 22164810Sliz D, Smith A, Wiebking C, Northoff G, Hayley S. Neural correlates of a single-session massage treatment. Brain Imaging Behav. 2012 Mar;6(1):77-87. doi: 10.1007/s11682-011-9146-z.
PubMed 22261925McCullough JE, Liddle SD, Sinclair M, Close C, Hughes CM. The physiological and biochemical outcomes associated with a reflexology treatment: a systematic review. Evid Based Complement Alternat Med. 2014;2014:502123. doi: 10.1155/2014/502123. Epub 2014 May 5.
PubMed 24883067
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised ,Blind, Placebo Controlled in Meir Center. Study the Potential of Reflexology Treatments to Help Implant Pregnancy in Ivf Patients
- ClinicalTrials.gov ID
- NCT02418364
- Acronym / sponsor ID
- 0020-15
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services, Reidman college
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end. It is often said that the couple suffers from infertility if for a year they could not get a normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30% are attributed to men, while the other 40% of cases are attributed to the combination between men and women and for unknown reasons. In women, the source of most of the problems of infertility are associated with different failures in ovulation (early ovulation, lack of ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to endometriosis, infection or surgery), problems in the uterus and endometrium. There is a group of women that apparently does not have the failures described above, and they have infertility that does not include pathological findings. Apparently chronic stress is a potential cause among couples who could not get pregnant (despite 6 months of focused sex) so there is a request for various techniques for reducing stress including yoga and meditation. One common option in various conditions of infertility is in vitro fertilization. This technique is also known as artificial insemination and is the most common technique used in Israel. Data from the Ministry of Health from the last years, indicate that the rate of successful pregnancies after embryo transfer is more than a third (in average), this is from an average of 20 treatment cycles.
Researches in alternative medicine are not easy to carry out. The placebo group which is usually the control group tend to be a treatment group by itself and gives effective results than a group that does not receive treatment at all. Carrying out a strict study with a good control group such as reflexology research in multiple sclerosis, has brought significant results in various statistical measures examined in this study (movement, sensory mode and urinary tract symptoms).
In the control group the calf was chosen as a place of a massage as a dummy treatment (gynecological place), which prevented contact with specific points of the feet like in patients in the treatment group. This study wishes to answer the research question: Does reflexology treatment increase the chances of pregnancy implantation in women without pathological findings that are treated with IVF. Other questions related to measures that could lead to the implant of pregnancy, are whether reflexology treatment affect the endometrial thickness, number of oocytes and embryo quality. Literature indicates the potential of reflexology treatment on ovulation induction (But requires a good control group and large sample size).
Detailed description
The purpose of the study:
Does reflexology treatment increase the chance of pregnancy in women treated with IVF?
Research design:
To the Study will recruited women who come for IVF treatments.
Women who are fit to participate and give their consent, will be randomized to one of three treatment groups:
Group 1 - placebo reflexology
Group 2 - control group that receives no alternative treatment. Data will be taken from questionnaires
Group 3 - will be receiving a built-in protocol reflexology treatment
Reflexology treatment can begin at any stage up to the stage of the eggs implantation. If the patient is not pregnant, she will start another reflexology treatment cycle. Reflexology treatment will be minimum 4 treatments and up to six treatments for every cycle. Rate treatment will be two or three times a week. The patient can receive reflexology treatment for three cycles of IVF.
Research tools and methods
- Photo of feet before the first treatment and before final treatment
- Permanent set by 4 parameters
- Questionnaire: to be transferred at baseline and after treatment and will be in a state of double blinded. There will be no connection between the treatment protocol and questionnaires. At the end of the study, the analysis and cross checking data will form their own measurements.
- Quality of Life Questionnaire
- Questionnaire "dhak"
- Mind-body questionnaire
- Family support questionnaire
Medical tests (measurements taken any way and will be used for the study): blood tests, medical record indicating that there is no pathological findings, ultrasound, endometrial thickness, number of follicles, number of oocytes and embryo quality.
Evaluation of Participants:
80 - experimental group 80 - a control group that receives no alternative treatment 80 - a group that receives a placebo treatments
Duration of participation in the study: Six months
Treatment protocol:
The treatment strengthens the natural healing of the body, in that it strengthens the blood flow and the release of endorphins, which can reduce pain, stress relaxation and a general feeling better (wellbeing). Recently a promising theory was added, a theory called Nerve Impulse the suggests that pressure points in the foot improve neural connection to other parts of the body through the autonomic nervous system. The autonomic nervous system, regulates body systems that are under unaware control such as respiratory, heart rate and blood pressure systems which are sensitive to pressure and vibration in accordance with Physical and psychological changes, and able to control the sympathetic system and moderate the fight or flight response. Recent meta-analysis that scanned many articles pointed out that there is no unity in studies about reflexology, that there are a wide range of parameters, methods and measurements of efficacy .Therapeutic Touch are complex and it is difficult to maintain such double-blind trials.
Therefore, there is a great need for maintaining the uniformity of treatment. In the investigators' study, will be responsible coordinator of reflexology, Rachel Hoddov, to teach and train coaches participating in the study protocol the standard treatment in a way that will allow a free hand. In addition, Placebo treatment will be in superficial areas in particular, and will be directed to organs and organ systems which are not relevant to the research topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo reflexology | Placebo comparator | Other: Placebo reflexology treatmentPlacebo reflexology treatment |
| control group | No intervention | –Data will be taken from questionnaires |
| reflexology treatment | Experimental | Other: Reflexology treatmentReflexology treatment |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women age 18 To 42
- women who receive IVF treatment
- The number of IVF cycles - up to 7 cycles
- Signing an informed consent form.
- patient is required to receive at least 4 reflexology treatments until the eggs implant.
Key exclusion criteria (2 listed)
- Women under 18 or over 42
- patients who had 7 cycles of IVF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo reflexology treatmentPlacebo reflexology treatment will be done in the same rate as the reflexology treatment itself, but will be superficial in particular,and will be directed to organs and organ systems which are not relevant to the research topic. | Other | placebo reflexology |
| Reflexology treatmentReflexology treatment will be done until the eggs implant. If the patient is not pregnant, she will start another reflexology treatment cycle. There will be minimum 4 and up to 6 reflexology treatments in every IVF cycle (maximum three IVF cycles) . Rate treatment will be two or three times a week. | Other | reflexology treatment |
Primary outcome
number of pregnant women in women treated with implantation in IVF
Time frame: 6 Months
Does reflexology treatment increase the number of pregnant women in women treated with implantation in IVF
3 secondary outcomes
endometrial thickness
Time frame: 6 months
number of oocytes
Time frame: 6 months
embryo quality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Background: PubMed 7490200Templeton A. Infertility-epidemiology, aetiology and effective management. Health Bull (Edinb). 1995 Sep;53(5):294-8.
- Background: PubMed 19740047Ernst E. Is reflexology an effective intervention? A systematic review of randomised controlled trials. Med J Aust. 2009 Sep 7;191(5):263-6. doi: 10.5694/j.1326-5377.2009.tb02780.x.
- Background: PubMed 17459741Poole H, Glenn S, Murphy P. A randomised controlled study of reflexology for the management of chronic low back pain. Eur J Pain. 2007 Nov;11(8):878-87. doi: 10.1016/j.ejpain.2007.01.006. Epub 2007 Apr 24.
- Background: PubMed 12926840Siev-Ner I, Gamus D, Lerner-Geva L, Achiron A. Reflexology treatment relieves symptoms of multiple sclerosis: a randomized controlled study. Mult Scler. 2003 Aug;9(4):356-61. doi: 10.1191/1352458503ms925oa.
- Background: PubMed 18565520Holt J, Lord J, Acharya U, White A, O'Neill N, Shaw S, Barton A. The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial. Fertil Steril. 2009 Jun;91(6):2514-9. doi: 10.1016/j.fertnstert.2008.04.016. Epub 2008 Jun 20.
- Background: PubMed 10460981Sudmeier I, Bodner G, Egger I, Mur E, Ulmer H, Herold M. [Changes of renal blood flow during organ-associated foot reflexology measured by color Doppler sonography]. Forsch Komplementarmed. 1999 Jun;6(3):129-34. doi: 10.1159/000021238. German.
- Background: PubMed 22164810Hughes CM, Krirsnakriengkrai S, Kumar S, McDonough SM. The effect of reflexology on the autonomic nervous system in healthy adults: a feasibility study. Altern Ther Health Med. 2011 May-Jun;17(3):32-7.
- Background: PubMed 22261925Sliz D, Smith A, Wiebking C, Northoff G, Hayley S. Neural correlates of a single-session massage treatment. Brain Imaging Behav. 2012 Mar;6(1):77-87. doi: 10.1007/s11682-011-9146-z.
- Background: PubMed 24883067McCullough JE, Liddle SD, Sinclair M, Close C, Hughes CM. The physiological and biochemical outcomes associated with a reflexology treatment: a systematic review. Evid Based Complement Alternat Med. 2014;2014:502123. doi: 10.1155/2014/502123. Epub 2014 May 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology treatment in people with Infertility, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liat Edry, PhD (0508520296, liatedry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of pregnant women in women treated with implantation in IVF (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418364, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.